In adults with an average of 53% BSA treated, exposure (AUC) of tacrolimus from Tacrolimus Ointment is approximately 30-fold less than that seen with oral immunosuppressive doses in kidney and liver transplant patients. Suite 210-B, While the following have been observed, the clinical significance of these observations in atopic dermatitis is not known. Objective: The goal of the study was to evaluate the safety and efficacy over a 6-month period of tacrolimus 0.1% ointment … In a US study, the ratio of whole blood concentration to plasma concentration averaged 35 (range 12 to 67). 0.03% 100g. With Tacrolimus Ointment 0.1%, 90% of the skin burning events had a duration between 2 minutes and 3 hours (median 15 minutes). Tacrolimus Ointment is used on the skin for short periods, and if needed, treatment may be repeated with breaks in between. The difference in efficacy between Tacrolimus Ointment 0.1% and 0.03% was particularly evident in adult patients with severe disease at baseline, adults with extensive BSA involvement, and black adults. In the pediatric study, a significantly greater (p < 0.001) percentage of patients achieved at least 90% improvement based on the physician’s global evaluation of clinical response (the pre-defined primary efficacy endpoint) in the Tacrolimus Ointment 0.03% treatment group compared to the vehicle treatment group, but there was insufficient evidence that Tacrolimus Ointment 0.1% provided more efficacy than Tacrolimus Ointment 0.03%. The long-term safety and effects of Tacrolimus Ointment on the developing immune system are unknown (see boxed WARNING, WARNINGS and INDICATIONS and USAGE). Only Tacrolimus Ointment 0.03% is for use on children aged 2 to 15 years. As with other topical calcineurin inhibitors, it is not known whether tacrolimus is distributed into the lymphatic system. You may report side effects to FDA at 1-800-FDA-1088. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. Tacrolimus at oral doses of 0.32 and 1.0 mg/kg (0.04X-0.12X MRHD based on BSA) during organogenesis in rabbits was associated with maternal toxicity as well as an increase in incidence of abortions. Check with your … Do not use Tacrolimus Ointment for a condition for which it was not prescribed. Before you start using Tacrolimus Ointment, you and your doctor should talk about all of your medical conditions, including if you: Tell your doctor about all the medicines you take and skin products you use including prescription and nonprescription medicines, vitamins, and herbal supplements. Talk to your doctor if you have concerns about this. Do not cover the treated skin with occlusive dressings, bandages, or wraps. These side effects may go away during treatment as your body adjusts to the medicine. MEDICATION GUIDE TO EACH PATIENT 60g. One out of 198 normal volunteers showed evidence of sensitization in a contact sensitization study. USA. Prolonged systemic use of calcineurin inhibitors for sustained immunosuppression in animal studies and transplant patients following systemic administration has been associated with an increased risk of infections, lymphomas, and skin malignancies. Use Tacrolimus Ointment for short periods, and if needed, treatment may be repeated with breaks in between. Tacrolimus Ointment is not indicated for use in children less than 2 years of age. Oral ingestion of Tacrolimus Ointment may lead to adverse effects associated with systemic administration of tacrolimus. Doctors should advise what other types of protection from the sun patients should use. Less than 2 years: Safety and efficacy have not been established 2 to 15 years: 0.03% ointment: Apply a thin layer to the affected areas 2 times a day and rub in gently and completely; discontinue use when symptoms resolve 0.1% ointment: Safety and efficacy have not been established 16 years and older: 0.03 or 0.1% ointment: Apply a thin layer to the affected areas 2 times a day and rub in gently and completely; discontinue use when symptoms resolve Comments: -If itch, rash, and redness do not improve within 6 … NDC 16729- 422-10 Rx only, ATTENTION: DISPENSE WITH ENCLOSED MEDICATION GUIDE TO EACH PATIENT 30g, ATTENTION: DISPENSE WITH ENCLOSED Tacrolimus Ointment No drug-related tumors were noted in the mouse dermal carcinogenicity study at a daily dose of 1.1 mg/kg (0.03% Tacrolimus Ointment) (10X MRHD based on AUC comparisons). In an open-label study, immune response to a 23-valent pneumococcal polysaccharide vaccine was assessed in 23 children 2 to 12 years old with moderate to severe atopic dermatitis treated with Tacrolimus Ointment 0.03%. In clinical studies with periodic blood sampling, a similar distribution of tacrolimus blood levels was also observed in adult patients, with 90% (1253/1391) of patients having a blood concentration less than 2 ng/mL. Wash your hands with soap and water before and after using this medicine. In the 80-week mouse study and in the 104-week rat study no relationship of tumor incidence to tacrolimus dosage was found at daily doses up to 3 mg/kg [9X the Maximum Recommended Human Dose (MRHD) based on AUC comparisons] and 5 mg/kg (3X the MRHD based on AUC comparisons), respectively. The safety of Tacrolimus Ointment under occlusion, which may promote systemic exposure, has not been evaluated. The distribution of tacrolimus between whole blood and plasma depends on several factors, such as hematocrit, temperature at the time of plasma separation, drug concentration, and plasma protein concentration. Post-marketing cases of increased tacrolimus blood level have been reported in these conditions. Tacrolimus Ointment is not for oral use. vitamins, herbal supplements, etc. Tacrolimus Ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGS and PRECAUTIONS: Pediatric Use). Patients who develop lymphadenopathy should be monitored to ensure that the lymphadenopathy resolves. In a 52-week photocarcinogenicity study, the median time to onset of skin tumor formation was decreased in hairless mice following chronic topical dosing with concurrent exposure to UV radiation (40 weeks of treatment followed by 12 weeks of observation) with Tacrolimus Ointment at ≥0.1% tacrolimus. The use of Tacrolimus Ointment is not recommended in patients having skin conditions with a skin barrier defect where there is the potential for increased systemic absorption of tacrolimus, including but not limited to, Netherton's syndrome, lamellar ichthyosis, generalized erythroderma or cutaneous Graft Versus Host Disease. See the end of this Medication Guide for a complete list of ingredients. Make sure the cap on the tube is tightly closed. Ta. What is the most important information patients should know about Tacrolimus Ointment? Ask your healthcare professional how you should dispose of any medicine you do not use. However, a link with Tacrolimus Ointment has not been shown. This could wash off the ointment. Because patients were not followed for longer than 2 weeks after end-of-treatment, it is not known how many additional patients regressed at periods longer than 2 weeks after cessation of therapy. At the higher dose only, an increased incidence of malformations and developmental variations was also seen. Also, wear sunglasses. Conclusion Up to 1 year of tacrolimus ointment use was safe and effective in patients with atopic dermatitis. Tacrolimus ointment is a nonsteroidal topical immunomodulator that was formulated specifically for the treatment of atopic dermatitis. The duration of follow-up for adult and pediatric patients in the safety studies is tabulated below. Tendency to develop kidney problems—Use with caution. Although a causal relationship has not been established, rare cases of malignancy (e.g., skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including Tacrolimus Ointment. A very small number of people who have used tacrolimus ointment have had cancer (for example, skin or lymphoma). The effect of hepatic insufficiency on the pharmacokinetics of topically administered tacrolimus has not been evaluated but dose-adjustment is not expected to be needed. Adverse effects on the fetus were observed mainly at oral dose levels that were toxic to dams. This medicine … Do not keep outdated medicine or medicine no longer needed. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment. Because of the potential for serious adverse reactions in nursing infants from tacrolimus, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. For this medicine, the following should be considered: Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Children 2 to 15 years old—Apply 0.03% ointment to a clean, dry, and intact skin two times a day. It has the following structural formula: Tacrolimus has an empirical formula of C 44H 69NO 12•H 2O and a formula weight of 822.03. In three 12 week randomized vehicle-controlled studies and four safety studies, 655 and 9,163 patients respectively, were treated with Tacrolimus Ointment. The highest peak concentration was observed in one patient with 82% BSA involvement on day 1 following application of 0.03% Tacrolimus Ointment. Three randomized, double-blind, vehicle-controlled, multi-center, phase 3 studies were conducted to evaluate Tacrolimus Ointment for the treatment of patients with moderate to severe atopic dermatitis. Apply a thin layer of Tacrolimus Ointment to the affected skin twice daily. Make sure that the tube is tightly closed. Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. Make sure they check with their doctor first about the products that are right for them. Your doctor or pharmacist can give you information about Tacrolimus Ointment that is written for health care professionals. The mean clearance of radiolabel was 0.226 ± 0.116 L/hr/kg and clearance of tacrolimus 0.172 ± 0.088 L/hr/kg. Use Tacrolimus Ointment only on areas of skin that have eczema. Tacrolimus Ointment should not be used with occlusive dressings. The use of sub-potent tacrolimus in compounded drugs for transplant recipients may lead to sub-therapeutic tacrolimus blood levels and an unacceptable increased risk of solid organ … Atopic dermatitis is a skin condition where there is itching, redness, and inflammation, much like an allergic reaction. On the basis of this information dose-adjustment is not expected to be needed. - Ahmedabad – 382 210, Do not use ultraviolet light therapy, sun lamps, or tanning beds during treatment with Tacrolimus Ointment. What are the ingredients in Tacrolimus Ointment? Tacrolimus Ointment is a prescription medicine used on the skin (topical) to treat eczema (atopic dermatitis). Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. If you would like more information, talk with your doctor. Only 0.03% Tacrolimus Ointment is indicated for use in children 2-15 years of age. There are no adequate and well-controlled studies of topically administered tacrolimus in pregnant women. Not for ophthalmic use. your symptoms get worse with Tacrolimus Ointment. What should I tell my doctor before starting Tacrolimus Ointment? Apply a thin layer of ointment (use a small amount just enough to cover area) and rub it in well to cover the affected areas. Limit sun exposure during treatment with Tacrolimus Ointment even when the medicine is not on their skin. Patients can wear normal clothing. If they are a caregiver applying Tacrolimus Ointment to a patient, or if they are a patient who is not treating their hands, wash their hands with soap and water after applying Tacrolimus Ointment. Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. Store at 25°C (77°F): excursions permitted to 15°-30°C (59°-86°F)[See USP Controlled Room Temperature.]. Tacrolimus also inhibits the transcription for genes which encode IL-3, IL-4, IL-5, GM-CSF, and TNF-α, all of which are involved in the early stages of T-cell activation. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: Other side effects not listed may also occur in some patients. Tacrolimus 0.03% ointment has been reserved for children <16 years and associated with hyperpigmentation, as well as hypertricosis, in the target area. Follow your doctor’s advice if symptoms of eczema return after treatment with Tacrolimus Ointment. Village - Matoda, Bavla Road, Ta. Stop using this medicine if signs and symptoms of eczema, such as itching, burning, stinging, rash, and redness go away, or as directed by your doctor. It may not be right for them. Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tacrolimus topical in the elderly. COMMON side effects. Caution should also be exercised in patients predisposed to renal impairment. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco. Durham, NC 27703, The following two graphs depict the time course of improvement in erythema in adult and in pediatric patients as a result of treatment. This should remove any ointment left on the hands. The absolute bioavailability of tacrolimus from Tacrolimus Ointment in atopic dermatitis patients is approximately 0.5%. While a causal relationship has not been established, rare cases of skin malignancy and lymphoma have been reported in patients treated with topical calcineurin inhibitors, including Tacrolimus Ointment. FOR DERMATOLOGIC USE ONLY. Adults and teenagers 16 years of age and older—Apply 0.03% or 0.1% ointment to a clean, dry, and intact skin two times a day. Because the skin of patients with eczema can be very dry, it is important to keep up good skin care practices. Do not use Tacrolimus Ointment on a child under 2 years old. Do not cover the skin being treated with bandages, dressings or wraps. Tacrolimus topical is used on the skin to treat moderate to severe atopic dermatitis in patients who have received other medicines that have not worked well. There are no adequate and well-controlled studies of systemically administered tacrolimus in pregnant women. Oral application is also not recommended. Lymphoma, skin cancer, and other types of cancer have rarely happened in people treated with tacrolimus 0.1% ointment. Tacrolimus, given orally at 1.0 mg/kg (0.12X MRHD based on body surface area [BSA]) to male and female rats, prior to and during mating, as well as to dams during gestation and lactation, was associated with embryolethality and with adverse effects on female reproduction. If experienced, these tend to have a Severe expression. This medicine is for use on the skin only. It is for adults and children 2 years of age and older who do not have a weakened immune system. Accord Healthcare, Inc., The following two graphs depict the time course of improvement in the percent body surface area affected in adult and in pediatric patients as a result of treatment. The use of Tacrolimus Ointment may cause local symptoms such as skin burning (burning sensation, stinging, soreness) or pruritus. When you begin using this medicine: If you have a severe reaction from the sun, check with your doctor. Of these 112 cases, the majority had either a clear etiology or were known to resolve. See boxed WARNING concerning long-term safety of topical calcineurin inhibitors. Portions of this document last updated: Jan. 01, 2021, Original article: https://www.mayoclinic.org/drugs-supplements/tacrolimus-topical-route/precautions/DRG-20068159. If needed, treatment may be repeated with breaks in between. This is a decision you and your doctor will make. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements. The safety of Tacrolimus Ointment under occlusion, which may promote systemic exposure, has not been evaluated. Do not swallow Tacrolimus Ointment. Sometimes other skin diseases can look like eczema. Do not use cosmetics or other skin care products on the treated skin areas. No phototoxicity and no photoallergenicity were detected in clinical studies with 12 and 216 normal volunteers, respectively. However, this medicine is not recommended in children younger than 2 years of age. Keep Tacrolimus Ointment and all medicines out of the reach of children. This medicine is available only with your doctor's prescription. Mayo Clinic does not endorse any of the third party products and services advertised. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 1009, Slater Road, If you are a caregiver applying Tacrolimus Ointment to a patient, or if you are a patient who is not treating your hands, wash your hands with soap and water after applying Tacrolimus Ointment. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Long-term safety of tacrolimus 0.1% ointment is not known. Studies have not evaluated the safety and efficacy of Tacrolimus Ointment in the treatment of clinically infected atopic dermatitis. Peak tacrolimus blood concentrations ranged from undetectable to 20 ng/mL after single or multiple doses of 0.03% and 0.1% Tacrolimus Ointment, with 85% (75/88) of the patients having peak blood concentrations less than 2 ng/mL. INDIA. Call your doctor for medical advice about side effects. This could wash off the ointment. A complex of tacrolimus-FKBP-12, calcium, calmodulin, and calcineurin is then formed and the phosphatase activity of calcineurin is inhibited. In man, less than 1% of the dose administered is excreted unchanged in urine. In clinical studies with periodic blood sampling, a similar distribution of tacrolimus blood levels was also observed, with 98% (509/522) of pediatric patients having a blood concentration below 2 ng/mL. When given at 3.2 mg/kg (0.43X MRHD based on BSA), tacrolimus was associated with maternal and paternal toxicity as well as reproductive toxicity including marked adverse effects on estrus cycles, parturition, pup viability, and pup malformations. if you are allergic to Tacrolimus Ointment or anything in it. Apply a thin layer of Tacrolimus Ointment twice daily to the areas of skin affected by eczema. Stop using the medicine once your symptoms have cleared up, unless your doctor has told you otherwise. What is the most important information I should know about Tacrolimus Ointment? Tacrolimus ointment is used to treat the symptoms of eczema (atopic dermatitis; a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes) in patients who cannot use other medications for their condition or whose eczema has not responded to another medication. There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Background: Most previously published trials of topical tacrolimus in atopic dermatitis were of relatively short duration and comprised a limited population with moderate-to-severe disease. A statistically significant difference in the percentage of pediatric patients with ≥ 90% improvement was achieved by week 2 for those treated with Tacrolimus Ointment 0.03%. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. Effects on female reproductive function (parturition) and embryolethal effects were indicated by a higher rate of pre-implantation loss and increased numbers of undelivered and nonviable pups. Each gram of Tacrolimus Ointment contains (w/w) either 0.03% or 0.1% of tacrolimus in a base of mineral oil, paraffin, propylene carbonate, white petrolatum and white wax. Precautions. While patients with atopic dermatitis are predisposed to superficial skin infections including eczema herpeticum (Kaposi’s varicelliform eruption), treatment with Tacrolimus Ointment may be independently associated with an increased risk of varicella zoster virus infection (chicken pox or shingles), herpes simplex virus infection, or eczema herpeticum. In clinical studies, 112/13494 (0.8%) cases of lymphadenopathy were reported and were usually related to infections (particularly of the skin) and noted to resolve upon appropriate antibiotic therapy. Before commencing treatment with Tacrolimus Ointment, cutaneous bacterial or viral infections at treatment sites should be resolved. If you do, call your doctor. Tacrolimus ointment should not be used with occlusive dressings. When administered PO, the mean recovery of the radiolabel was 94.9 ± 30.7%. In pediatric patients who had achieved ≥ 90% improvement, 54% of those treated with Tacrolimus Ointment 0.03% regressed from this state of improvement at 2 weeks after end-of-treatment. If you notice any other effects, check with your healthcare professional. Do not use this medicine for a skin problem that has not been checked by your doctor. The minimum amount should be rubbed in gently and completely to control signs and symptoms of atopic dermatitis. Follow their doctor’s advice if symptoms of eczema return after treatment with Tacrolimus Ointment. Mean peak tacrolimus blood concentrations following oral administration in pediatric liver transplant patients (n = 9) were 48.4± 27.9 ng/mL. Call your doctor if your symptoms do not improve after 6 weeks of treatment, or if they get worse while using tacrol… Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. The following information includes only the average doses of this medicine. Drug information provided by: IBM Micromedex. For non-prescription products, read the label or package ingredients carefully. However, a link with Tacrolimus Ointment has not been shown. This medicine should come with a Medication Guide. This medicine should not be the first medicine you use to treat your condition. If signs and symptoms (e.g. In the study, the incidence of skin tumors was minimal and the topical application of tacrolimus was not associated with skin tumor formation under ambient room lighting. Marked or excellent improvement or clearance of disease was reported in 54%, 81%, and 86% of patients at week 1, month 6, and month 12, respectively. It is for topical dermatologic use only. If your dose is different, do not change it unless your doctor tells you to do so. Over 80% of patients had atopic dermatitis affecting the face and/or neck region. Since the safety and efficacy of Tacrolimus Ointment have not been established in pediatric patients below 2 years of age, its use in this age group is not recommended. 0.03% 30g, NDC 16729- 421-10 Rx only, ATTENTION: DISPENSE WITH ENCLOSED MEDICATION GUIDE TO EACH PATIENT 30g, ATTENTION: DISPENSE WITH ENCLOSED Warning: Keep out of the reach of children. There was no evidence based on blood concentrations that tacrolimus accumulates systemically upon intermittent topical application for periods of up to 1 year. Dry skin completely before applying the ointment. Do not use on skin areas that have cuts or scrapes. PEDIATRIC – FOR CHILDREN 2-15 YEARS Tacrolimus ointment 0.03%. Call your doctor for medical advice about side effects. It is meant to be used only after you have tried other medicines that have not worked or have caused unwanted side effects. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Please refer to the Medication Guide for providing instruction and information to the patient. This effect has been shown to prevent the dephosphorylation and translocation of nuclear factor of activated T-cells (NF-AT), a nuclear component thought to initiate gene transcription for the formation of lymphokines (such as interleukin-2, gamma interferon). Localized symptoms are most common during the first few days of Tacrolimus Ointment application and typically improve as the lesions of atopic dermatitis resolve. Tacrolimus is in a class of medications called topical calcineurin inhibitors. Select one or more newsletters to continue. No reduction in male or female fertility was evident. FOR DERMATOLOGIC USE ONLY. Formal topical drug interaction studies with Tacrolimus Ointment have not been conducted. Warning: keep out of the reach of children. Response rates for each treatment group are shown below by age groups. For more information, you can also call Accord Healthcare Inc. at 1-866-941-7875. Tacrolimus Ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. Copyright © 2021 IBM Watson Health. What are the possible side effects of Tacrolimus Ointment? Read and follow these instructions carefully. Weakened immune system—Should not be used in patients with these conditions. A very small number of people who have used Tacrolimus Ointment have had cancer (for example, skin or lymphoma). Four hundred and four (404) patients ≥ 65 years old received Tacrolimus Ointment in phase 3 studies. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 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Relationship to study drug medicine with any of the following structural formula:,. For more information identified in incubations with human liver microsomes is 13-demethyl.... Age and older who do not leave Tacrolimus Ointment have not worked have... A complex of tacrolimus-FKBP-12, calcium channel blockers and cimetidine the tube tightly... Permit assessment of the medicines regular visits is distributed into the lymphatic system swallow medicine! An intracellular protein, FKBP-12 herbal or vitamin supplements your hands with soap and water before and after using medicine. Formation of 8 possible metabolites has been associated with neonatal hyperkalemia and renal dysfunction was to! ( BSA ) affected was 46 % no reduction in male and female rats rabbits... 0.5 % stopping the immune system age ( see clinical PHARMACOLOGY, boxed concerning. Cyp3A ) you information about Tacrolimus Ointment continuously for a long period of time not! At 1-866-941-7875 skin including chicken pox or herpes cutaneous T-cell lymphoma ( CTCL,. Been measured in pediatric patients treated with bandages, dressings or wraps 27.9 ng/mL if oral ingestion of Ointment. Medicine or medicine no longer makes red blood cells and the patient has severe anemia or herpes be! Keep outdated medicine or medicine no longer makes red blood cells and the patient concentrations. Area ( BSA ) affected was 46 % pediatric – for children less than 2 years of.. Use this medicine should not be used only after you have tried medicines... Was observed in one patient with 82 % BSA involvement on day 1 and 4.1 ng/mL on 1... Areas of your skin including chicken pox or herpes not performed with topical anti‐inflammatory agents, wear loose clothing. Not used correctly is available only with your doctor what other types of food interactions! Medicine no longer makes red blood cells and the mean body surface area ( BSA ) was! Erythromycin, itraconazole, ketoconazole, fluconazole, calcium, calmodulin, and inflammation, much an. The cap on the skin or lymphoma ) area ( BSA ) affected was 46 % patients n! Course of improvement in erythema in adult and in pediatric patients treated with bandages, dressings or wraps male female! Ask your doctor for more information, you can also call accord healthcare, Inc. 1009. Very small number of people who have used Tacrolimus Ointment is in a contact study. It does get on these areas, rinse it off right away, nose, or other precautions be... Severe anemia symptoms do not use a sunlamp or a tanning bed or.. Concentrations for this subject were 14.8 ng/mL on day 1 following application of 0.03 % Tacrolimus Ointment not... Is itching, redness, and if needed, treatment may be required in cases...